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Terminated

OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri) The -B4036V-NS cannula is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a polybag. The polybag is sealed and labeled. Typically there are 100 trays per polybag.

FDA Recall Z-1601-05 · Posted 2005-10-01

Recalling FirmOasis Medical Inc
Recall StatusTerminated
Product CodeKYG
Date Initiated2005-08-24
Date Terminated2014-03-24
Product Quantity9,859 cannulas for all codes

Reason for Recall

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators

Firm Action

OASIS Medical shall inform all customers that have received the product via FAX and Certified Mail to cease use immediately and return all unused product to OASIS.

Root Cause

Other

Distribution Pattern

Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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